A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors
This study is currently recruiting participants.
Verified November 2012 by Merrimack Pharmaceuticals
Sponsor:
Merrimack Pharmaceuticals
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01733004
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: MM-141 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Merrimack Pharmaceuticals:
Primary Outcome Measures:
- Severity and number of adverse events related to escalating doses of MM-141 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
MM-141 monotherapy
|
Drug: MM-141 |
|
Experimental: Arm B
MM-141 and Everolimus
|
Drug: MM-141 |
|
Experimental: Arm C
MM-141 and Docetaxel
|
Drug: MM-141 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
- Eighteen years of age or above
- Able to understand and sign an informed consent (or have a legal representative who is able to do so)
- Measurable disease according to RECIST v1.1
- ECOG Performance Score of 0 or 1
- Adequate bone marrow, hepatic, renal and cardiac function
- Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141
Exclusion Criteria:
- Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
- Symptomatic CNS disease
- Received other recent antitumor therapy
- Pregnant or breast feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733004
Contacts
| Contact: Akos Czibere, MD, PhD | 617-441-1000 |
Locations
| United States, Georgia | |
| Georgia Cancer Specialists | Recruiting |
| Marietta, Georgia, United States | |
| Contact: Christopher Moore, RHIT, CTR 770-496-9427 christopher.moore@gacancer.com | |
| United States, Michigan | |
| Karmanos Cancer Institute | Not yet recruiting |
| Detroit, Michigan, United States | |
| Contact: Karen Forman, BAA, CCRP 313-576-8096 formank@karmanos.org | |
Sponsors and Collaborators
Merrimack Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Merrimack Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01733004 History of Changes |
| Other Study ID Numbers: | MM-141-01-01-01 |
| Study First Received: | November 20, 2012 |
| Last Updated: | November 26, 2012 |
| Health Authority: | United States: Food and Drug Administration France: Agence Nationale de Sécurité du Médicament et des produits de Santé |
Keywords provided by Merrimack Pharmaceuticals:
|
Cancer Solid tumors Oncology Phase I |
ErbB3 IGF-1R Everolimus Docetaxel |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013